FDA accepts Roche Molecular Systems product
Swiss pharmaceutical company Roche said this week that its
supplement to the AMPLICOR(TM) HIV-1 Test, version 1.5 has been
accepted for review by the US Food and Drug Administration (FDA).
Roche Molecular Systems, the in vitro diagnostics element of Swiss pharmaceutical company Roche said this week that its supplement to the AMPLICOR(TM) HIV-1 Test, version 1.5 has been accepted for review by the US Food and Drug Administration (FDA).
This supplement provides data in support of the automation of the purification step using the COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5. The COBAS AmpliPrep/COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5, uses polymerase chain reaction (PCR) technology to measure the amount of HIV-1 RNA (viral load) present in an infected person's blood.
The COBAS AmpliPrep/COBAS AMPLICOR HIV-1 MONITOR Test, v1.5 was designed to address the increasing needs of clinical laboratories to enhance productivity and reduce operational costs.
The COBAS AmpliPrep instrument automates the purification of HIV-1 RNA, together with the COBAS AMPLICOR instrument, which uses PCR technology to amplify and identify genetic material. This allows for accurate detection of even small amounts of viral RNA in the blood.
"Classical non-automated PCR methods are labour intensive. The use of the AmpliPrep and COBAS AMPLICOR instruments to automate the classic PCR process has been shown to reduce the hands-on-time of specimen preparation, amplification and detection by 60 - 80 per cent," said Prof. Donald Jungkind, Director of the Clinical Microbiology Laboratory at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania, and principal investigator in early evaluations of this new assay. "Time saved by using this new system was significant and will increase overall laboratory productivity and result integrity while lowering labour costs."
